Recruiting

Radiation Therapy

Sponsor:

University Health Network, Toronto

Code:

NCT07348887

Conditions

Squamous Cell Cancer of Head and Neck (SCCHN)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Daily adaptive radiation therapy

Image guided radiation therapy

Study Details

Brief summary:

This is a randomized, single centre, single blinded prospective study comparing the standard of care imaging guided radiation therapy and daily adaptive radiotherapy (ART) for submandibular gland-sparing in head and neck cancer

Conditions

Squamous Cell Cancer of Head and Neck (SCCHN)

Study ID

NCT07348887

Start date

Oct 15, 2025

Status verified date

Mar, 2026

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Oct 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18 years
  • Histologically proven Squamous Cell carcinoma of head and neck
  • Bilateral neck being treated
  • At least one level 1b not being treated electively and with no target structure, other than elective level II/III, <1cm to spared SMG
  • ECOG PS 0-2
  • Planned for curative (chemo)radiotherapy
  • Able to receive and understand verbal and written information regarding study and able to give written informed consent
  • Be able to lie comfortably on back and to wear immobilization for up to 1 hour

Exclusion Criteria:

  • As judged by investigator evidence of systemic disease that makes unsuitable for study
  • Pregnancy
  • Underlying salivary dysfunction prior to treatment judged by investigator to affect likelihood of benefit from ART

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Image guided radiation therapy

This arm will proceed as per the standard of care. The pre-treatment reference plan will be delivered daily for 35 fractions. If a notable change in anatomy is identified, a dose of the day calculation may be performed as per current standard head and neck workflow

experimental: Daily Adaptive Radiation Therapy

Structures of daily adaptive radiation therapy organ at risk will be AI generated in the Ethos platform on the daily CBCT and then edited by radiation therapy team as required. A rigid registration of CTV targets to the CBCT replicating the current radiation therapy led IGRT process.

Interventions

Daily adaptive radiation therapy

Adaptive radiotherapy (ART) is the modification of the radiotherapy plan during treatment to account of changes from the original anatomy and set up. Reduction in treatment volume can be achieved through ART by:

1. adjusting for gradual longitudinal changes in tumour and anatomy
2. adjusting to account for uncertainty in set up and anatomy via daily online

Image guided radiation therapy

The pre-treatment reference plan will be delivered daily for 35 fractions.

Primary outcome measure

  • Change in saliva production [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Andrew McPartlin, MD

416-946-2132andrew.mcpartlin@uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Andrew McPartlin, MD

416-946-4501andrew.mcpartlin@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-04.